SH
Shire Human Genetic Therapies, Inc.8 Tage
Associate Director, Drug Product Manufacturing Science & Technology(m/w/x)
Vollzeit
Senior
Keine Angabe
Zürich, Opfikon, Wien, Linz, Oranienburg
Nejo KI-Zusammenfassung
In this role, you will be the go-to expert for small-molecule drug product manufacturing, leading process characterization and technology transfers while driving continuous improvement strategies. Your work will ensure robust and compliant manufacturing practices across a global network.
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Anforderungen
- •Bachelor’s degree in Chemistry, Chemical Engineering, or related discipline
- •At least 5 years of industrial experience in pharmaceutical development and manufacturing
- •Deep expertise in drug product manufacturing technologies for oral solid dosage forms and/or injectable products
- •Experience as a subject matter expert in a matrix environment
- •Strong analytical and problem-solving skills
- •Excellent communication skills for explaining complex technical concepts
- •Ability to focus on critical priorities and deliver high-quality results
- •Intellectual curiosity about technology and new ways of working
- •Willingness to travel to international manufacturing sites
Bachelor-Abschluss
Berufserfahrung
5 Jahre
Deine Aufgaben
- •Serve as the global expert for small-molecule oral solid dose and parenteral drug product manufacturing technologies
- •Lead drug product manufacturing process characterization and define critical process parameters and control strategies
- •Oversee technology transfer of drug product and packaging processes to internal manufacturing sites and CMOs
- •Ensure smooth and compliant implementation of processes during technology transfer
- •Validate drug product and packaging processes in accordance with regulatory and Takeda standards
- •Participate in rapid response teams to resolve complex manufacturing issues using data-driven root cause analysis
- •Drive continuous improvement strategies for marketed drug products in their late lifecycle phase
- •Shape and implement manufacturing strategies for key Takeda products in collaboration with Pharmaceutical Sciences and Operations
- •Capture, share, and leverage process knowledge and best practices across sites and functions
- •Partner with local Technical Services, site leadership, Pharmaceutical Sciences, Global Quality, and Regulatory CMC to align on technical decisions
Sprachen
Englisch – verhandlungssicher
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